BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 2854197 · Received November 29, 2012

    Report

    Report Number
    3007700286-2012-00068
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    August 23, 2012
    Report Date
    November 29, 2012
    Manufacturer
    SI-BONE
    Product Code
    OUR
    PMA / PMN Number
    K080398
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED UPON THE COMPLAINT INFO AND INVESTIGATION, AS WELL AS REVIEW OF THE SURGEON TRAINING MANUAL, CERTIFICATE OF CONFORMANCE AND (B)(4), THERE IS NO INDICATION OF DEVICE FAILURE OR THAT THE DEVICE WAS OUT OF SPECIFICATION. THE MOST PROBABLE ROOT CAUSE IS IMPLANT PLACEMENT THROUGH THE ICBG DEFECT AND IMPLANT MALPOSITION.

    Description of Event or Problem · 1

    THE SURGEON PERFORMED A LEFT SI JOINT FUSION UTILIZING THE IFUSE IMPLANT SYSTEM ON (B)(6) 2011. THE IMPLANTS WERE PLACED IN THE VICINITY OF THE ICBG (ILIAC CREST BONE GRAFT) DEFECT WITH AT LEAST ONE IMPLANT GOING THROUGH THE DEFECT. THE PT DID VERY WELL AFTER SURGERY WITH A MARKED IMPROVEMENT IN HER BUTTOCK PAIN BUT HAD SOME EARLY ONSET PAIN AT 3 -4 WEEKS POST OPERATIVELY. BY 11 WEEKS AFTER SURGERY, HER BUTTOCK PAIN HAD RETURNED TO BASELINE. BY 5 MONTHS POST OPERATIVELY, HER PAIN WAS "WORSE THAN BEFORE". X-RAYS WERE OBTAINED WHICH WERE DESCRIBED AS "OK". A CT SCAN WAS PERFORMED. THE SECOND AND MORE MARKEDLY THE THIRD IMPLANTS WERE SHORT AND WERE NOT FULLY ENGAGED INTO THE SACRUM. AN MRI OF THE LUMBAR SPINE WAS PERFORMED AND NO NEW LUMBAR PATHOLOGY WAS IDENTIFIED. A DIAGNOSTIC SI JOINT INJECTION WAS PERFORMED. THIS GAVE THE PT SIGNIFICANT PAIN RELIEF FOR A COUPLE OF DAYS. ON (B)(6) 2012, THE SURGEON SURGICALLY REMOVED THE 2 CAUDAL IMPLANTS. THE IMPLANTS CAME OUT EASILY. PER REPORT OF THE SURGEON, THERE WAS NO BONE ON THE IMPLANTS. A 12 X 45 MM GLOBUS SCREW WAS PLACED IN THE MIDDLE HOLE. HE PLACED DBM (DEMINERALIZED BONE MATRIX) IN THE DISTAL HOLE. HE THEN REMOVED THE PROXIMAL IMPLANT AND REPLACED IT WITH A 12 X 45 MM GLOBUS SCREW. THIS IMPLANT ALSO CAME OUT QUITE EASILY. THIS IMPLANT ALSO HAD "NO BONE ONGROWTH". THE PT HAS DONE WELL AFTER REVISION SURGERY. THE PT WAS SEEN IN CLINIC 6 WEEKS AFTER SURGERY. THE PT'S SIJ PAIN IS MUCH IMPROVED. SI-BONE'S VP OF MEDICAL AFFAIRS REVIEW OF THIS CASE "BRINGS INTO CONSIDERATION THE ANATOMIC "RISK FACTOR" OF THE ICBG DEFECT IN THE ILIAC CREST. THE FIRST IMPLANT WAS PLACED THROUGH THIS DEFECT. THE SECOND AND THIRD IMPLANTS WERE NOT DEEPLY ENGAGED INTO THE SACRUM AS THEY WERE SHORT AND POSSIBLY DORSAL. I AM ALSO CONCERNED THAT THE PT MAY HAVE HAD COMPROMISED BONE QUALITY AS SHE WAS A (B)(6) FEMALE WITH A HISTORY OF MULTIPLE SPINE SURGERIES. NO DEXA SCAN WAS AVAILABLE FOR REVIEW."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IFUSE IMPLANT SYSTEM PLATES, SCREWS, RODS OUR SI-BONE

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention